Trial management plays an important role throughout the product development process of product life cycle management. From the early stages of product design and development, to industrialization, it is important to have proper tools to prove product quality, and to evaluate the production process of trials in a consistent way. During the product development process, trials have to be carried out and evaluated. Carrying out trials requires functions as those provided in the execution, and quality management of regular manufacturing, but with a higher flexibility.
Trials based on recipe management (RM) system recipes may be executed without any additional maintenance of master data on a bench scale or pilot plant scale. Factory trials may also be supported. All results of a trial, including in-process, post-process, and further analyses, are recorded and may be evaluated. A trial object may then deliver a recipe, including key manufacturing instructions, and additional information concerning manufacturing and quality management.
However, to allow efficient product development, the trials within the different stages of development—bench scale, pilot plant scale, and factory scale—need to be supported by a sufficient data structure. Functions need to be provided allowing maintenance of specifications and recipes.
A trial is an action for testing a product in order to achieve the required product quality/specification. During pilot plant phases, a trial allows finding product specifications for a product on a defined product line at optimal cost. More specifically, a trial is the manufacture of a product by using a recipe. A recipe may consist of formula, processing conditions, quality inspection parameters, in-process control, and equipment specification. Not all of these parameters are required. A recipe also allows the subsequent evaluation of all trial results. The trial may be carried out on a bench scale, pilot plant scale, or industrial scale.
A document providing information for product development on a pilot plant scale and an industrial scale might be a preliminary manufacturing dossier (PMD). This PMD describes a production situation in a factory. Such a document may be required for any production start up of a new product.
A PMD template may comprise material specifications, ingredients, and packaging materials, recipes comprising formulae, manufacturing instructions, process block diagrams, in-process controls, and equipment specifications. Furthermore, a finished product specification with all quality management data required for a post-process control, and product release may be included. In addition, label declaration, transport, and storage information may be included.
However, during trials different specifications, recipes, and equipment specifications are necessary for different stages. With known methods, it is not possible to recycle data, which have already been acquired during previous stages. For each stage, the relevant information has to be manually copied. Also, process flow is not supported. Furthermore, users are not provided with a data structure that guides them through the different stages of a product development process.
For different stages within a development process, different actions, recipes, formulae and equipment specifications are necessary. Users have to manually select these to provide trial results for later trial evaluation. This manual selection is error prone.